What changed
FDA published a draft guidance (January 2025) titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” FDA’s landing page identifies it as Draft, Level 1 guidance and “Not for implementation,” and lists Docket FDA-2024-D-4689 with a link to a Federal Register notice. The draft PDF states that comments should be submitted within 90 days of publication in the Federal Register notice announcing the draft document.
Why it matters
Although not PV-specific, the FDA draft guidance explicitly addresses AI used to support regulatory decision-making for drugs and biologics—an area that can overlap with PV outputs when AI tools generate or transform analyses, summaries, or interpretations that could influence regulated safety conclusions or be reused in regulatory interactions. For PV and quality organizations, this raises near-term governance and inspection/submission readiness considerations: knowing which AI-enabled outputs could be referenced in regulated contexts, who owns them (including vendors), and whether documentation and controls are sufficiently robust to support oversight and change management expectations signaled by FDA’s draft framework.
Practical implication
1) Inventory AI use cases that could feed regulated decisions (including PV/safety-related analyses or summaries used in regulatory interactions) and map owners/vendors. 2) For each AI use case, document context of use, intended outputs, and controls (e.g., review/approval, traceability, change management) aligned to a draft-guidance tracking plan. 3) Track the Federal Register notice and plan whether to submit comments within the window described by FDA (90 days after Federal Register publication).